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Ooops! just checked the date, you're right.

Never the less CEO stated on the 12 June that it was in the queue to be rubber stamped by FDA.

The movement is a result of that! Market makers know!

June 2019 for FDA approval

https://m.youtube.com/watch?v=GLUNyyCCdu4

Listen to Interview in Dec 2018

He states FDA approval coming in June 2019.

Not even 2000 available?

https://m.youtube.com/watch?v=GLUNyyCCdu4 Listen to Interview in Dec 2018 He states FDA approval coming in June 2019!

Will be even more exciting when FDA approval lands!

Yes no quotes online NT only!

https://www.imagingbiometrics.com/more-information/news-events/press-releases/

A day closer to FDA approval! All those big sells absorbed by the MM’s Mcap too cheap!

David Smith, CEO of IB, commented: "For the first time IQ-AI's full range of products will have direct sales representation worldwide. We are very excited about the shared revenue potential of this agreement. CorTechs Labs has a well established and rapidly growing sales and marketing team who can introduce IB's portfolio to their existing and new clients." Dr. Chris Airriess, CEO of CorTechs Labs said: "We are delighted to partner with IQ-AI to help bring their innovative products to market. The StoneChecker and Imaging Biometrics products are very complementary with ours and help solve important clinical challenges faced by our global customer base."

Too cheap, Considering FDA approval coming

Mcap only 3.7 million Too low for what IQAI are doing

Shares outstanding 120.35m Free float 48.87m https://markets.ft.com/data/equities/tearsheet/summary?s=FBDU:LSE

https://youtu.be/6BCSZIi5VQE

Listen: 5.54min into interview
& 7:08 mins into interview

Then make your own decision!

https://youtu.be/6BCSZIi5VQE

StoneChecker was originally submitted to FDA in May 2018. Under the FDA's 510k guidelines, manufacturers are required to compare the new product to an existing FDA cleared product. This represented a challenge since StoneChecker has some unique features which are not found in other "predicate" products. A CT machine software was chosen to establish "substantial equivalence" to StoneChecker, but after several discussions with FDA it was mutually agreed that a different comparator device be used. Consequently, the 510k package was resubmitted to them and they formally accepted it on 22 August 2018.

On 5 October 2018, we received correspondence from the FDA that the original package needed supplemental information and we were invited to discuss this with them to seek clarification. A conference call followed on 30 October 2018.

During that call it seemed that the Agency clearly understood the purpose of StoneChecker but asked for additional information to be presented to show how the product might work in situations where suboptimal CT images had been obtained. The FDA wanted to be confident that StoneChecker could still provide reliable data output when attempting to analyse poor input data. The Company has gone back to the original clinical data that was developed to verify that this kind of data exists and has submitted a response to the FDA with a proposed test method outlined that, the Board believes, would satisfy them that StoneChecker will function under these more challenging conditions. This additional testing methodology was submitted to the FDA on 27 November 2018 for their evaluation.

This represents the normal application process with the FDA for a 510k. The manufacturer submits a data package for review. The FDA examines it for completeness, then starts working on it. At any point they can 'stop the clock' to ask questions, and that clock restarts when the manufacturer submits answers. The FDA is evaluated against a standard, and processes 95% of 510k's within 90 days of the FDA review time. Given that the StoneChecker application has now been with them for over half that time it appears that while approval may be forthcoming at the end of the year, it is more likely that the FDA may not complete their review of the package until Q1 2019.

https://www.investegate.co.uk/iq-ai-limited--iqai-/rns/stonechecker-510k-update/201812130700023154K/

Listen to the interview: FDA don't want any further information. https://youtu.be/6BCSZIi5VQE

IB StoneChecker® analysis software is in the final stages of FDA clearance for distribution in the US and will also be added to the CorTechs' portfolio, internationally. StoneChecker provides a critical tool in the management of kidney stone treatment. The software analyses 32 different standardised parameters to distinguish kidney stone size, location and composition to provide conclusive data that determines if lithotripsy is an effective treatment option.



IB software's suite of quantitative and automated tools includes StoneChecker, IB Neuro and IB Delta® Suite. Clinically validated through decades of research, IB Neuro provides critical data about tumor biology that had not previously been available through conventional MR imaging. It is the only image perfusion solution available that automatically generates quantitative (standardised) relative cerebral blood volume (rCBV) maps, independent of scanner, field strength, patient or time point. It is also the only pathologically confirmed neuroimaging software product. IB Delta Suite automates quantitative difference (Delta T1) maps that help clinicians clearly distinguish tumor progression from treatment effect. IB's products complement those of CorTechs Labs which specialise in assessing neurological conditions, including Alzheimer's disease, multiple sclerosis, epilepsy and traumatic brain injury.

He states FDA approval is in the queue for a rubber stamp, and no further information is required from IQAI

Published on 12 Jun 2019
IQ-AI Limited’s (LON:IQAI) David Smith caught up with Proactive London's Andrew Scott after announcing that Imaging Biometrics has signed a non-exclusive business development and sales deal with brain analysis firm CorTechs Labs.

Smith says the deal gives them extended and immediate sales representation in the US and other international markets.

He adds that product sales have continued to accelerate in 2019 and as a result they're expecting full year 2019 numbers to be more than double those for 2018.

https://youtu.be/6BCSZIi5VQE

Off topic

Check out IQAI to recoup MTFB losses

FDA approval imminent!

hxxps://youtu.be/6BCSZIi5VQE

Watch video!
Mcap far too low! 3.5m

Only 120m shares in issue

https://youtu.be/6BCSZIi5VQE

Watch video!
Mcap far too low!